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Company Announces Positive Results from Clinical Trial of a Generic Glatiramer Acetate in Relapsing-Remitting MS

March 27, 2014

In a study of 796 people with relapsing-remitting MS at sites worldwide, GTR (generic glatiramer acetate, Synthon BV) reduced disease activity on MRI scans similarly to Copaxone® (glatiramer acetate, Teva Pharmaceutical Industries Ltd) in a nine-month trial. The results were announced in a March 27, 2014 press release from Synthon BV. The company has submitted an application to the FDA for approval of GTR to treat MS, and plans to submit an application to European regulatory authorities as well, according to the press release.

Background: Glatiramer acetate is a synthetic compound that simulates myelin basic protein, a component of the myelin that insulates nerve fibers in the brain and spinal cord. This therapy seems to block myelin-damaging T-cells through a mechanism that is not completely understood. Currently glatiramer acetate is available as Copaxone and is approved by the FDA to reduce the frequency of relapses in patients with relapsing-remitting MS and for use in individuals who have experienced a first clinical episode (clinically-isolated syndrome) and have MRI features that are consistent with MS. This study compared a generic form of glatiramer acetate with Copaxone.

The Study: Participants were randomly assigned to receive GTR (20 mg/day injected under the skin), Copaxone (20 mg/day injected under the skin), or inactive placebo (injected daily under the skin) for nine months. In an ongoing extension study, participants who complete the first 9 months are being treated with GTR (20 mg/day) for 15 months.

The primary goal of the study was to compare the effectiveness of GTR, Copaxone and placebo for reducing disease activity seen on MRI brain scans. Other objectives included comparing the effectiveness of reducing relapse rates, improving scores on clinical scales, and safety.

Disease activity was equally reduced in both the Synthon GTR and the Copaxone groups, and significantly reduced when compared with the placebo group, according to the press release. According to the press release, there were similar results for the other study objectives, but details of these results are not provided. Reported adverse reactions were similar between the GTR and Copaxone groups and in line with those known to be associated with Copaxone.

Conclusion: Full details of the study are expected to be submitted for publication in a peer-reviewed medical journal and presented at future scientific meetings. Synthon submitted an Abbreviated New Drug Application for the approval of GTR as a generic therapy to the U.S. Food and Drug Administration in November 2011, and plans to submit an application to European drug regulatory authorities as well.

“We look forward to seeing the complete data from this study,” says Timothy Coetzee, PhD, Chief Advocacy, Services, and Research Officer of the National MS Society. “Having additional treatment options is important for people with MS, since everyone responds to therapies differently.”

About Multiple Sclerosis

Multiple sclerosis, an unpredictable, often disabling disease of the central nervous system, interrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.